VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Level of gE-specific IgG in serum.
研究概览
简要总结
To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating T-cells
详细描述
This is an interventional study of vaccination related to infection with varicella zoster virus. We will enroll participants of two age groups. Cohort 1 will be persons between the ages of 30-40; Cohort 2 will be persons who are 70 years of age or older. All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1: 30-40 years of age
- •Cohort 2: 70 years of age or older
- •HIV seronegative
排除标准
- •Previous vaccination with Shingrix (RZV), Zostavax (ZVL, zoster vaccine live), or with the chickenpox vaccine
- •VZV seronegative
- •Active Hepatitis C infection or active Hepatitis B infection. Persons with serologic evidence of hepatitis C infection that has cleared spontaneously, or with a history of treated hepatitis C with a sustained virologic response, can be enrolled. Persons with a history of resolved hepatitis B infection (negative for hepatitis B surface antigen) can be enrolled
- •History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction) to any component of the vaccine
- •History of receipt of an organ transplant or hematopoietic stem cell transplant
- •Significant autoimmune disease such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, scleroderma, dermatomyositis, or other condition which in the past has required significant immune modifying medication or which has a clinical course that is characterized by relapses
- •Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
- •Has long-term use of oral or parenteral steroids (>7 days), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed)
- •Women of child-bearing potential only: pregnant, breastfeeding, or planning to become pregnant 3 months post vaccination
- •Has an acute or chronic medical condition that, in the opinion of the investigator, would render biopsies unsafe
- •History of coagulopathy or taking medication that may cause bleeding (long term high dose aspirin, heparin, coumadin). Aspirin doses <100 mg daily allowed
- •History of keloid formation or excessive scarring
- •History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy
- •Allergy to lidocaine, silver nitrate, or mupirocin
- •Has any condition or medical history that would, in the opinion of the site principal investigator place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
研究组 & 干预措施
Cohort 1: 30-40 year of age
干预措施: Shingrix (Drug)
Cohort 2: 70 years of age or older
干预措施: Shingrix (Drug)
结局指标
主要结局
Level of gE-specific IgG in serum.
时间窗: up to 1 year after vaccination
Units will be optical density at 492 nanometers from ELISA.
Level of gE-specific CD4 T cells in blood
时间窗: up to 1 year after vaccination
Units will be cells per million CD4+ T cells in blood.
Cytokine profile of gE-specific CD4 T cells in blood
时间窗: up to 1 year after vaccination
Units will be percent of gE-reactive T cells expressing single T cell cytokines or combinations of cytokines
次要结局
未报告次要终点
研究者
Christine Johnston
Associate Professor: School of Medicine
University of Washington